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临床试验/NCT01638793
NCT01638793已完成不适用

Capnographic Monitoring of Propofol-sedation During Colonoscopy

Johann Wolfgang Goethe University Hospital4 个研究点 分布在 1 个国家目标入组 528 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
528
试验地点
4
主要终点
Hypoxia (SO2 <90%)

研究概览

简要总结

The present study is a randomized, prospective, single-blinded study. Patients presenting for colonoscopy under sedation will be included according to the statistical sample size calculation. Patients will be randomized to either group 1- capnographic monitoring or group 2- oxygenic monitoring during Propofol-based sedation for colonoscopy. Episodes of Hypoxia are documented and compared in both groups.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Indication for colonoscopy
  • Patient wishing sedation during colonoscopy
  • ≥ 18 years of age
  • Signed informed consent form

排除标准

  • Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases)
  • Non-contractually capable persons
  • Pregnancy
  • Lactation

结局指标

主要结局

Hypoxia (SO2 <90%)

Study objective is to evaluate if a reduction of hypoxic events (SO2 \<90% for ≥ 15 sec) can be obtained with capnographic monitoring as compared to standard monitoring of respiration with pulse-oxymetry in patients receiving colonoscopy under Propofol-based sedation

次要结局

  • Severe Hypoxia (SO2 <85%)
  • Time to hypoxia
  • Hypoxia in relation to sedation
  • Vegetative Symptoms

研究者

发起方
Johann Wolfgang Goethe University Hospital
申办方类型
Other

研究点 (4)

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